FDA 510(k) clearances — page 388
clearances on record, most recent first.
Clearances — page 388
38,701–38,800 of 175,770- K133858 — TENSYN BAND
- K133999 — DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
- K140227 — MONODERM SURGICAL SUTURE
- K140283 — OSTEOMED EXTREMIFUSE SYSTEM
- K131876 — M SERIES PATIENT MONITOR
- K132553 — U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
- K132811 — SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
- K132957 — MADSEN ACCUSCREEN TYPE 1077
- K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
- K133647 — EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
- K133773 — SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
- K133854 — ARTHREX IBALANCE TKA SYSTEM
- K140033 — TARGET3D FUSION
- K140178 — ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- K123162 — U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
- K123508 — TRINIAS
- K130650 — STATUS DS OXY
- K131598 — ANAL RECTAL OVERTUBE
- K131626 — EXCELERON BACTERIAL FILTERS
- K131770 — PRESSURE CONNECTING TUBE
- K131791 — IFA 40: HEP-20-10
- K132496 — ARTHROSURFACE TOEMOTION
- K132889 — FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
- K133018 — OSI Q SYSTEM ARTHROSCOPES
- K133385 — LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
- K133517 — NEMUS 2 SYSTEM
- K133536 — EMERGE MEDICAL BONE PLATE SYSTEM
- K140034 — SUREFIRE GUIDING CATHETER
- K140254 — EZONO 4000
- K140282 — ST SENSE NV 8 ARRAY COIL
- K130517 — EZ TRANSPORT CHAIR
- K130580 — RETRACTION PASTE
- K131503 — SE-601 SERIES ELECTROCARDIOGRAPH
- K132344 — E-Z CHECK OZONE TEST STRIPS
- K132389 — CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
- K132599 — SMILEBOND SYSTEM
- K132690 — UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
- K132814 — SFI-BAR IMPLANT ABUTMENTS
- K133058 — INSULIN PEN NEEDLE
- K133059 — INSULIN PEN NEEDLE
- K133137 — CISNAP CLOSED INCISION SYSTEM
- K133162 — ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
- K133177 — MODIFIED HD GUIDE CATHETER
- K133287 — PRESSON SPINAL FIXATION SYSTEM
- K133320 — SICAT FUNCTION
- K133501 — LEADLINER CS LEAD DELIVERY SYSTEM
- K133644 — SYNGO.VIA MI WORKFLOWS
- K133696 — NEODENT IMPLANT SYSTEM
- K133904 — CD HORIZON SPINAL SYSTEM GROWTH ROD SET
- K133968 — WONDFO MULTI-DRUG URINE TEST CUP, PANEL
- K134020 — INTONEMV
- K140118 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
- K123697 — MATRICEL DENTAL BARRIER MEMBRANE
- K131252 — PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
- K131909 — DALTON LIFT CHAIR
- K132480 — AIR-FLOW HANDY 3.0 PERIO
- K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
- K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
- K133510 — NEODENT IMPLANT SYSTEM
- K133615 — WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
- K133625 — AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
- K133691 — EXTRIMILOCK ANKLE PLATING SYSTEM
- K131066 — AXIOM REG
- K131426 — MEDLINE BIOPSY VALVE
- K131481 — FREEDOM PCK COMPONENTS
- K131783 — POLAROID CONTACTSPOD
- K131990 — OXYGEN GENERATOR LIQUEFIER - (OGL)
- K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
- K132158 — NOVOHIP TOTAL HIP SYSTEM
- K132219 — STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
- K132229 — OMNI PATENT MONITORS
- K132402 — SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
- K132457 — FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
- K132842 — FLAATZ 600 SERIES (FLAATZ 600/601)
- K132874 — LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
- K132935 — ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME
- K133234 — T-TYPE D-KAT, R-TYPE D-KAT
- K133409 — DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
- K133432 — SHERPA PAK CARDIAC TRANSPORT SYSTEM
- K133491 — ADVIA CENTAUR TESTOSTERONE (TSTO)
- K133509 — EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
- K133576 — MONITOR B40
- K133710 — LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
- K133948 — BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
- K131041 — ADVANCED PERFUSION SYSTEM 1
- K131145 — PROINSERT
- K131196 — INFANT PHOTOTHERAPY BILITRON SKY 5006
- K131772 — CANTATA(R) 2.9 MICROCATHETER
- K132321 — JMS SYRINGE
- K132949 — PELLEFIRM
- K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
- K133567 — UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
- K133585 — INBONE TOTAL ANKLE
- K133617 — JAZZ SYSTEM
- K140160 — RELIEVA SCOUT SINUS DILATION SYSTEM
- K132323 — RS-3000 ADVANCE
- K132958 — MEDICINAL LEECHES
- K133564 — MODIFICATION TO NAUTILUS SPINAL SYSTEM
- K133845 — 8MM TROCAR KIT
- K140030 — DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.